FDA Revitalization Act renamed, amended and still hotly debated; floor vote is imminent

Tuesday, May 01, 2007 by Mike Adams, the Health Ranger Editor of NaturalNews.com (See all articles...) Tags: the FDA, FDA reform, health news

The hotly-debated S.1082 legislation sponsored by Sen. Kennedy has now been renamed the Enhancing Drug Safety and Innovation Act of 2007, reports Brenna Hill of the Health Freedom Foundation and American Association (www.HealthFreedom.net). The bill is being hotly debated and has been delayed by two days due to the introduction of various amendments. The health freedom community is continuing its grassroots efforts to rally public support for defeating the bill, even while some lawmakers such as Sen. Byron Dorgan are proposing much-needed amendments that would vastly improve it.

Health freedom author and nutritional supplement formulator Byron Richards has spearheaded much of the commentary on this bill, and support for defeating the bill has come from many camps in the health freedom movement, including the Life Extension Foundation (www.LEF.org), raw foods pioneer Dr. Gabriel Cousens (www.TreeofLife.nu), John Hammel's International Advocate for Health Freedom (www.nocodexgenocide.com), the National Health Federation (www.TheNFH.com) and many others. Even Freedom to Fascism producer Aaron Russo (www.freedomtofascism.com) is closely monitoring this situation and sending health freedom email updates to his subscribers.

Hundreds of thousands of comments and complaints have already been received by U.S. lawmakers concerning this bill. The latest update of legislative maneuvers is provided by Byron Richards in an article reprinted here with permission from www.NewsWithViews.com

Of special interest is the development of a new amendment that would end the U.S. pharmaceutical monopoly and allow Americans to purchase prescription drugs from other countries. This single amendment, which would bring free trade to medications and save American citizens, corporations, cities and states billions of dollars in reduced pricing for prescription drugs, has Big Pharma and their legislative lapdogs circling the wagons, hoping to pass this bill quickly before any other "bright ideas" threaten Big Pharma's stanglehold on organized medicine.

What's at stake here is nothing less than the future of our nation. Because if we cannot end this medical monopoly and radically reform the FDA, Big Pharma will bankrupt our national economy and leave America broke, diseased and medicated from the cradle to the grave.

Here's the update as reported by Richards:

Fight Erupts on Senate floor: Senators Bribed by Big Pharma vs. Senators not Bought Off

By Byron Richards, CCN

As the Senate continues to debate the Big Pharma-friendly sweeping reform of the FDA a new problem for Big Pharma's prize Senators has erupted and quickly turned into confrontation on the floor of the Senate. At stake is at least 10 billion dollars per year in exorbitant Big Pharma profits. In one corner is Big Pharma-puppet Orrin Hatch (R-UT), representing the Kennedy/Enzi drug cartel. In the other corner is a majority of Senators lead by Byron Dorgan (D-ND).

At issue is an amendment that Dorgan has added to S1082, one that is vehemently opposed by the authors of the bill and by the White House. Dorgan's amendment calls for Americans to be able to purchase prescription drugs from other countries. This would bring to an end the Big Pharma price-fixing scam that has Americans paying at least twice as much for the same drugs. Hatch unsuccessfully pleaded with Dorgan (while attacking him) to withdraw the amendment. Bush is threatening to veto the entire bill if the Dorgan amendment is part of the legislation.

The Safety Scam

The Kennedy/Enzi/Hatch/Clinton drug-cartel Senators are now in a real jam. Dorgan has the votes to make his amendment stick. Hatch and company have argued unconvincingly that the Dorgan amendment would expose Americans to adulterated drug imports. This is just another fake safety argument that holds no water and is being made solely to protect the excessive profits of Big Pharma (as is the entire bill).

It should now be crystal clear to the American public that those behind this legislation have been completely purchased by the Big Pharma lobby. It is a complete joke that they are trying to pawn off this legislation as "safety legislation." This legislation is designed to protect Big Pharma profits for the next 50 years, and includes new FDA regulatory powers that can be used to stamp out Big Pharma competition - including dietary supplements. Let your Senators know that you support the Dorgan amendment.

A Vote is Likely on Thursday

Word from the hill is that all amendments and changes to this legislation will be finalized by Thursday and a vote will take place. In addition to the Dorgan amendment several other amendments are expected to come up - one very good and one very bad. The good amendment will be proposed by Senator Grassley (R-IA) and will seek to create an independent office within the FDA to monitor the safety of drugs already on the market (this would be another big blow to this legislation). The bad amendment will come from the vitamin-hating Dick Durbin (D-IL) who will try to place food safety legislation into this drug safety bill. Not only is his amendment completely irrelevant to this legislation, he will, as always, figure some way to attack dietary supplements. I'll keep you posted.

We must also get our amendment, THE PEOPLE'S AMENDMENT, into this legislation (see action letter at following this article).

The People are Now Being Heard

We have word that the offices of Hatch, Harkin, Enzi, Kennedy, and many other Senators are being flooded by your concerns regarding what this bill can do to undermine health freedom and your access to dietary supplements. Their offices are seeking to tell those who get through that we are confused and that the legislation is not about dietary supplements.

Don't buy this for a second. We are not confused. The language in the bill is crystal clear. It is a sneaky and devious wording buried in the bill. The Senate drug cartel hoped we wouldn't notice. On pages 106-107 it states: "The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety....The Foundation shall [take] into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including post approval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics."

This language has been evaluated by Jonathan Emord, our nation's leading attorney that defends health freedom, the man who has beaten the FDA in court more than any other lawyer. He states that this language gives the FDA, through this foundation, broad new regulatory power that it currently does not possess, including the authority to attack any dietary supplement (which are food ingredients). A simple amendment to correct this problem has been prepared by Emord and is in the action letter that follows.

WE ARE BEING HEARD. KEEP SENDING IN YOUR MESSAGES. There are two days to go. We can win this!

See recent updates at:
http://www.newswithviews.com/Richards/byron2...
http://www.newswithviews.com/Richards/byron2...

Sample letter

Anti S.1082 Food and Drug Revitalization Act
May 2, 2007
The Honorable (Senator First and Last Name)
(List their address here)

Dear Senator Last Name; The issue of drug safety and access to drugs at a fair price is of the utmost importance to myself and all Americans. In general, I am opposed to Senate bill S1082: Food and Drug Administration Revitalization Act, as it does not go far enough to protect myself and my family from the dangers of drugs. As one of the 150 million Americans that rely on dietary supplements to keep myself and my family well, I am especially concerned that this legislation broadens FDA regulatory power to harass functional foods and dietary supplements - which has nothing whatsoever to do with drug safety.

It is vital that the terms "food" and "food ingredients" be removed from this legislation. There must be no confusing the safety of drugs and the safety of food and food ingredients - which are governed by different laws. This bill authorizes, on pages 106-107, the creation of a new regulatory category that enables the FDA and the Reagan-Udall Foundation for the FDA to attack dietary supplements and functional foods. This problem in the wording can be corrected with this simple amendment - so as to be sure this legislation is about drugs and drug safety only.

Amendment to Bill S1082

Purpose of the amendment: The bill, S1082: The Food and Drug Administration Revitalization Act, is hereby amended to eliminate any reference to the terms food or food ingredients, such that food and food ingredients will not be subject to any jurisdiction or control by the Regan-Udall Foundation for the Food and Drug Administration.

Intent of amendment: To eliminate from the bill any possibility that food or food ingredients would be treated like drugs either for safety review purposes or for assessment of their efficacy. It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury

I am in favor of the Dorgan amendment that enables Americans to get a fair price on prescription medication.

I am in favor of any Grassley amendment that offers an independent office within the FDA to monitor the safety of drugs already on the market.

I am opposed to the amendment being prepared by Durbin, as food safety is a completely different issue and must be kept out of drug safety legislation so that there can be no confusion between drug safety and food safety laws - which are quite different.

Sincerely,

About Byron Richards: Richards is the founder of Wellness Resource (www.WellnessResources.com) and author of Fight For Your Health! The FDA's Betrayal of America